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    Summary
    EudraCT Number:2017-003659-52
    Sponsor's Protocol Code Number:PULSE
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2017-003659-52
    A.3Full title of the trial
    Impact of Iron Deficiency treatment with intravenous ferric carboxymaltose in patients with Chronic Obstructive Pulmonary Disease: an open-label, randomized, 2-arm, no treatment control, parallel study – PULSE study
    Impacto do tratamento da deficiência de ferro com carboximaltose férrica intravenosa em doentes com doença pulmonar obstrutiva crónica: estudo aberto, randomizado, de 2 braços, com controlo de não tratamento e paralelo – estudo PULSE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of Iron Deficiency treatment with intravenous ferric carboxymaltose in patients with Chronic Obstructive Pulmonary Disease
    Impacto do tratamento da deficiência de ferro com carboximaltose férrica intravenosa em doentes com doença pulmonar obstrutiva crónica
    A.3.2Name or abbreviated title of the trial where available
    PULSE Study
    A.4.1Sponsor's protocol code numberPULSE
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAntónio Robalo Nunes
    B.1.3.4CountryPortugal
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHospital das Forças Armadas
    B.4.2CountryPortugal
    B.4.1Name of organisation providing supportOM Pharma
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScientific Toolbox Consulting
    B.5.2Functional name of contact pointSilvia Sirgado
    B.5.3 Address:
    B.5.3.1Street AddressEstrada Paço do Lumiar, 44, Lt 01
    B.5.3.2Town/ cityLisboa
    B.5.3.3Post code1600-546
    B.5.3.4CountryPortugal
    B.5.4Telephone number+351210 992 121
    B.5.6E-mailsilvia.sirgado@sctbx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ferinject
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFerinject
    D.3.2Product code ATC-Code B03AC
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Obstructive Pulmonary Disease and Iron Deficiency
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease and Iron Deficiency
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the impact of ID treatment with intravenous ferric carboxymaltose in patients with COPD, on the 6MWT, after 8 weeks post baseline visit.
    E.2.2Secondary objectives of the trial
    - To explore the efficacy of ferric carboxymaltose in COPD patients with underlying ID in other clinical assessments of interest.
    - To assess the prevalence of ID in a cohort of COPD patients.
    - To assess the changes in hematological parameters of interest.
    - To assess the safety of ferric carboxymaltose in COPD patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male or female.
    2. COPD diagnosis, according to the Global Initiative for Obstructive Lung Disease (GOLD) guidelines from 2017.
    3. Iron Deficiency (ID) diagnosis according to the following criteria:
    o Ferritin < 100 µg/mL, or
    o Transferrin saturation <20%.
    4. Able and willing to provide written informed consent and comply with study requirements.
    E.4Principal exclusion criteria
    1. Known sensitivity to ferric carboxymaltose.
    2. Participating in a pulmonary rehabilitation program.
    3. Previously treated for Iron Deficiency (ID), either with oral or intravenous iron, in the past 3 months.
    4. Any underlying condition that causes hemorrhage during the patient’s participation in the trial.
    5. Moderate to severe hepatic impairment (Class B or greater), as determined by Child-Pugh classification; hemodialysis-dependent chronic kidney disease; or history of hepatic or renal conditions that may suggest being contraindications for ferric carboxymaltose treatment after a benefit/risk assessment.
    6. Under treatment which is contraindicated with ferric carboxymaltose or intravenous therapies, i.e. oral iron therapy.
    7. Woman of childbearing potential (WOCBP), defined as “fertile, following menarche and until becoming post-menopausal (i.e., no menses for 12 months without an alternative medical cause)”; unless permanently sterile.
    8. COPD exacerbations in the last 30 days.
    9. Active or chronic infection.
    10. Clinically significant laboratory results or any other significant condition that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
    E.5 End points
    E.5.1Primary end point(s)
    - 25-meters increase in 6MWT [time-frame: baseline versus 8 weeks].
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks post-baseline
    E.5.2Secondary end point(s)
    - Relative and absolute change in 6MWT distance [time-frame: baseline versus 8 weeks].
    - Relative and absolute change in peripherical oxygen saturation during 6MWT.
    - Relative and absolute change in Borg scale during 6MWT.
    - 2-point improvement in COPD assessment test (CAT) [time-frame: baseline versus 8 weeks].
    - Relative and absolute change in CAT scores [time-frame: baseline versus 8 weeks].
    - Relative and absolute change in Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC ratio, and Forced Expiratory Flow at 25-75% of FVC (FEF25-75%) [time-frame: baseline versus 8 weeks].
    - 10% increase in FEV1 [time-frame: baseline versus 8 weeks].
    - Proportion of patient achieving ID correction [time-frame: baseline versus 8 weeks].
    - Absolute and relative change in other relevant laboratory assessments [time-frame: baseline versus 8 weeks].
    - Use of rescue medication for COPD exacerbations.
    - Rate and severity of COPD exacerbations.
    - Patient Global Impression of Change (PGIC).
    - Clinician Global Impression of Change (CGIC).
    - Incidence of Adverse Events (AE).
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No treatment control
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    For the purpose of this study, a patient ends his/her participation in the study when he/she attends the last study visit or if he/she meets a withdrawal criterion. No data will be collected after the end of the study. Adverse events and concomitant medications will be considered closed in the clinical study database for each patient at the date and time of patient’s end of the study, even though additional information becomes available during the period of the study conduct.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of study, if ferric carboxymaltose proves effective and safe, treatment for ID with ferric carboxymaltose will be available for all eligible patients (according to SmPC).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-02
    P. End of Trial
    P.End of Trial StatusOngoing
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